Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DDS · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972812 | RAICHEM PREALBUMIN SPIA | Hemagen Diagnostics, Inc. | 1997-08-28 | 31 | 0 |
| K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | Beckman Instruments, Inc. | 1997-05-09 | 163 | 0 |
| K934966 | SPQ PAL CONTROL LEVEL II | Incstar Corp. | 1994-01-11 | 88 | 0 |
| K854811 | ICS PAB PREALBUMIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1986-01-24 | 52 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda